Cleared Traditional

K833688 - SUTURE REMOVAL KITS STERILE
(FDA 510(k) Clearance)

K833688 · Carwild Corp. · General & Plastic Surgery
May 1984
Decision
213d
Days
Class 1
Risk

K833688 is an FDA 510(k) clearance for the SUTURE REMOVAL KITS STERILE, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Carwild Corp. (Walker, US). The FDA issued a Cleared decision on May 31, 1984, 213 days after receiving the submission on October 31, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.

Submission Details

510(k) Number K833688 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1983
Decision Date May 31, 1984
Days to Decision 213 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code KGX — Tape And Bandage, Adhesive
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5240

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